A Multi-center Study of Spherule-Derived Coccidioidin

This study has been completed.

Sponsor:

Nielsen BioSciences, Inc.

ClinicalTrials.gov Identifier:

NCT00690092

First Posted: June 4, 2008

Last Update Posted: October 29, 2013

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Adult volunteers were skin tested with 1.27 ug spherule-derived coccidioidin. The skin test antigen was evaluated in three different populations of adult volunteers to determine the safety and efficacy of the product in the assessment of delayed-type hypersensitivity to Coccidioides immitis. Induration greater than or equal to 5 mm after 48 hours was considered positive for exposure to C. immitis.

To determine the ability of spherule-derived coccidioidin to detect cellular hypersensitivity to C. immitis by a positive DTH skin test in a population with a history of pulmonary coccidioidomycosis. [ Time Frame: 48 hours ]

Secondary Outcome Measures:

Determine the specificity of spherule-derived coccidioidin by testing the skin test antigen in naive adult volunteer and volunteers with a history of pulmonary histoplasmosis. [ Time Frame: 48 hours ]

Volunteers with a history of pulmonary coccidioidomycosis verified by serology and/or histology or mycology.

Biological: Spherule-derived coccidioidin

1.27 ug of sterile, injectable product (spherule-derived coccidioidin). Product was administered once by intradermal injection along with positive and negative control agents and results read after 48 hours.

Other Name: Coccidioidin SD (proposed trade name)

Active Comparator: 2

Volunteers without a history of pulmonary coccidioidomycosis confirmed by serology (naive).

Biological: Spherule-derived coccidioidin

1.27 ug of sterile, injectable product (spherule-derived coccidioidin). Product was administered once by intradermal injection along with positive and negative control agents and results read after 48 hours.

Other Name: Coccidioidin SD (proposed trade name)

Active Comparator: 3

Volunteers with a history of pulmonary histoplasmosis but no history of coccidioidomycosis confirmed by serology.

Biological: Spherule-derived coccidioidin

1.27 ug of sterile, injectable product (spherule-derived coccidioidin). Product was administered once by intradermal injection along with positive and negative control agents and results read after 48 hours.

Other Name: Coccidioidin SD (proposed trade name)

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

18 Years to 65 Years (Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Good Health (absence of active medical disease)

Meets criteria specific to population groups:

Coccidioidomycosis Group:

History of coccidioidomycosis of at least 45 days duration confirmed by roentgenograph serologic or mycologic findings